Pharmaceutical compositions for the treatment of tumors expressing EGFR and GM3 N-glycolyl ganglioside (NeuGcGM3)

Abstract

The present invention relates to pharmaceutical compositions for the treatment of malignant tumors. Particularly those tumors that express EGFR and GM3 N-glycolyl ganglioside targets to enhance the therapeutic effect produced by separated therapies against these targets. The pharmaceutical compositions of the invention include antibodies and/or vaccines against each of the targets. Additionally the present invention relates to methods for applying the compositions of the invention.

The invention claimed is: 
     
       1. A method for retarding tumor growth of a tumor that co-expresses EGFR and N-glycolyl GM3 (NeuGcGM3) ganglioside targets in a patient in need thereof, comprising:
 (a) administering to a patient a medicament comprising a monoclonal antibody (MAb) directed against EGFR and, 
 (b) administering to the same patient a medicament comprising a vaccine against NeuGcGM3 ganglioside. 
 
     
     
       2. The method according to  claim 1 , wherein
 (a) said MAb directed against EGFR is administered to said patient first and said vaccine against said NeuGcGM3 ganglioside is subsequently administered, or 
 (b) said vaccine against said NeuGcGM3 ganglioside is administered to said patient first and said MAb against EGFR is subsequently administered. 
 
     
     
       3. The method according to  claim 1 , wherein said MAb directed against EGFR and said vaccine against said NeuGcGM3 ganglioside are administered simultaneously, staggered or alternately to said patient. 
     
     
       4. The method according to  claim 1 , wherein the vaccine against NeuGcGM3 ganglioside is NeuGcGM3/VSSP vaccine or anti-idiotypic Racotumumab/Alumina vaccine. 
     
     
       5. The method according to  claim 1 , wherein the dosage of the Mab is in the range from approximately 100 to 400 mg. 
     
     
       6. The method according to  claim 4 , wherein the dose of the NeuGcGM3 vaccine or the anti-idiotypic vaccine is in the range from approximately 0.1 to 2 mg. 
     
     
       7. The method according to  claim 1 , wherein said MAb is Nimotuzumab Mab. 
     
     
       8. The method according to  claim 3 , wherein said MAb and said vaccine against said NeuGcGM3 ganglioside are administered simultaneously in the form of a composition. 
     
     
       9. The method according to  claim 1 , wherein the vaccine has NeuGcGM3/VSSP as active principle. 
     
     
       10. The method according to  claim 1 , wherein the vaccine is Racotumumab anti-idiotypic vaccine adjuvated with alumina. 
     
     
       11. The method according to  claim 1 , wherein said patient is suffering from a tumor that co-expresses EGFR and NeuGcGM3 ganglioside targets. 
     
     
       12. The method according to  claim 11 , wherein said patient is suffering from a cancer selected from the group consisting of lung, breast, digestive system, urogenital system and sarcoma tumors derived from neuroectodermic tissue, and lymphoproliferative disorders. 
     
     
       13. The method according to  claim 1 , further comprising treating said patient with conventional radiotherapy. 
     
     
       14. The method according to  claim 1 , further comprising treating said patient with conventional chemotherapy. 
     
     
       15. The method according to  claim 1 , further comprising treating said patient with conventional radiotherapy and chemotherapy. 
     
     
       16. The method according to  claim 1 , wherein the patient experiences at least a 37% increase in survival percentage after 24 months of administration of the Mab directed against EGFR and the vaccine against NeuGcGM3. 
     
     
       17. The method according to  claim 1 , wherein there is less than 10% fall-off in survival of human cancer patients after 24 months of administration of the MAb against EGFR and the vaccine against NeuGcGM3 ganglioside compared to 12 months of administration of the MAb against EGFR and the vaccine against NeuGcGM3 ganglioside. 
     
     
       18. The method of  claim 17 , wherein the less than 10% fall-off in survival occurs in lung cancer patients.